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The Impact on Ovarian Reserve After Single-port, Two-port, or Four-port Access Laparoscopic Ovarian Cyst Enucleation

Primary Purpose

Ovarian Cyst

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Laparoscopic ovarian cyst enucleation
Sponsored by
CHA University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cyst

Eligibility Criteria

21 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Age: 21-45 years Ultrasound
  • CT, MRI diagnosis as ovarian cyst , need to cyst enucleation
  • Size of cyst : between 3cm and 10cm
  • Regular menstrual cycles defined as cycle length between 25 and 35 days
  • Agreement to be enrolled in the study.

Exclusion Criteria:

  • Previous ovarian surgery
  • suspicious of malignancy
  • Postmenopause
  • Use of oral contraceptive drug, GnRH agonist /antagonist, or other drugs related with ovarian function in last 3 months
  • Known endocrine disorder

Sites / Locations

  • Gangnam CHA medical centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

single-port access laparoscopic ovarian cyst enucleation

two-port laparoscopic access ovarian cyst enucleation

four-port access laparoscopic ovarian cyst enucleation

Arm Description

Procedure: Operative laparoscopic ovarian cyst enucleation was performed only through an umbilical single port. ( 2 cm longitudinal incision was made within the umbilicus and an wound retractor (Alexis Wound Retractor XS) was inserted into the wound opening. A surgical glove with three 5mm trocars inserted into three fingers was draped around the rim of the wound retractor.)

Procedure: Operative access laparoscopic ovarian cyst enucleation was performed using an umbilical single port ( 2 cm longitudinal incision was made within the umbilicus and an wound retractor (Alexis Wound Retractor XS) was inserted into the wound opening. A surgical glove with two 5mm trocars inserted into two fingers was draped around the rim of the wound retractor.) and one 5-mm trocar in the lower abdomen.

Procedure: : Operative laparoscopic ovarian cyst enucleation was performed through insertion of a 12-mm subumbilical trocar and three 5-mm trocars in the lower abdomen.

Outcomes

Primary Outcome Measures

Preoperative and postoperative changes in anti-mullerian hormone level
The primary outcome of our study is the impact on ovarian reserve determined by AMH after the application of the three laparoscopic techniques for the treatment of ovarian cyst.In all study patients, at preoperation and 1 week, 1 month, 3 month after operation, AMH is serially measured.

Secondary Outcome Measures

postoperative pain scores

Full Information

First Posted
June 26, 2012
Last Updated
June 30, 2012
Sponsor
CHA University
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1. Study Identification

Unique Protocol Identification Number
NCT01631253
Brief Title
The Impact on Ovarian Reserve After Single-port, Two-port, or Four-port Access Laparoscopic Ovarian Cyst Enucleation
Official Title
The Impact on Ovarian Reserve After Single-port, Two-port, or Four-port Access Laparoscopic Ovarian Cyst Enucleation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
March 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CHA University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate the impact on ovarian reserve after single- port, two-port, or four-port access laparoscopic ovarian cyst enucleation based on serum anti mullerian hormone change.
Detailed Description
With the recent development of surgical instruments techniques, minimally invasive surgery is more feasible in various field of surgery. Laparoscopic surgery has potential benefit of decreased patient discomfort, short hospital stay, superior cosmetic results and decreased convalescence time. Recently, various efforts have been continued for minimally invasive surgery, one of the recently emerging concepts is single port surgery. Several studies have demonstrated that single-port laparoscopic surgery is feasible and safe in gynecology. However, some limits could be occurred, such as the occurrence of less freedom degrees between the instruments and limits surgical vision, thus limiting surgeon's movements. So, two-port laparoscopy combined access through umbilical and additional suprapubic incision have been used and reported. In case of single port access laparoscopic ovarian cyst enucleation, due to limits of surgeon's movements, cyst enucleation or bipolar electrocoagulation of the ovarian parenchyma adversely affected ovarian function. Some studies reported that after laparoscopic cyst enucleation, there had been shown marked reduction of ovarian function compared with surgery by laparotomy. Therefore we attempt to investigate the impact of single port laparoscopy that have limits of surgical procedures on ovarian reserve after ovarian cyst enucleation. To evaluate ovarian reserve change, we will use the anti-mullerian hormone. It is produced by granulosa cells of preantral and small antral follicles and has been recently acknowledged as the useful, reliable, and sensitive hormonal serum marker of the ovarian primordial follicle pool. In addition, the AMH level represents a stronger independent marker of ovarian reserve without significant fluctuation during the menstrual cycle, which progressively decreases with age. Therefore, this prospective study is performed to compare the differences in ovarian reserve after single-port, two-port, or four-port access laparoscopic ovarian cyst enucleation based on serum anti mullerian hormone change. Serum anti mullerian hormone is measured at preoperative and at postoperative 1week, 1 and 3 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cyst

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
single-port access laparoscopic ovarian cyst enucleation
Arm Type
Active Comparator
Arm Description
Procedure: Operative laparoscopic ovarian cyst enucleation was performed only through an umbilical single port. ( 2 cm longitudinal incision was made within the umbilicus and an wound retractor (Alexis Wound Retractor XS) was inserted into the wound opening. A surgical glove with three 5mm trocars inserted into three fingers was draped around the rim of the wound retractor.)
Arm Title
two-port laparoscopic access ovarian cyst enucleation
Arm Type
Active Comparator
Arm Description
Procedure: Operative access laparoscopic ovarian cyst enucleation was performed using an umbilical single port ( 2 cm longitudinal incision was made within the umbilicus and an wound retractor (Alexis Wound Retractor XS) was inserted into the wound opening. A surgical glove with two 5mm trocars inserted into two fingers was draped around the rim of the wound retractor.) and one 5-mm trocar in the lower abdomen.
Arm Title
four-port access laparoscopic ovarian cyst enucleation
Arm Type
Active Comparator
Arm Description
Procedure: : Operative laparoscopic ovarian cyst enucleation was performed through insertion of a 12-mm subumbilical trocar and three 5-mm trocars in the lower abdomen.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic ovarian cyst enucleation
Primary Outcome Measure Information:
Title
Preoperative and postoperative changes in anti-mullerian hormone level
Description
The primary outcome of our study is the impact on ovarian reserve determined by AMH after the application of the three laparoscopic techniques for the treatment of ovarian cyst.In all study patients, at preoperation and 1 week, 1 month, 3 month after operation, AMH is serially measured.
Time Frame
preoperative, postoperative at 1week, 1 and 3 months
Secondary Outcome Measure Information:
Title
postoperative pain scores

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 21-45 years Ultrasound CT, MRI diagnosis as ovarian cyst , need to cyst enucleation Size of cyst : between 3cm and 10cm Regular menstrual cycles defined as cycle length between 25 and 35 days Agreement to be enrolled in the study. Exclusion Criteria: Previous ovarian surgery suspicious of malignancy Postmenopause Use of oral contraceptive drug, GnRH agonist /antagonist, or other drugs related with ovarian function in last 3 months Known endocrine disorder
Facility Information:
Facility Name
Gangnam CHA medical center
City
Seoul
State/Province
Gamnamgu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
seok ju Seong
Email
sjseongcheil@yahoo.co.kr

12. IPD Sharing Statement

Citations:
PubMed Identifier
24630293
Citation
Yoon BS, Kim YS, Seong SJ, Song T, Kim ML, Kim MK, Paek JY. Impact on ovarian reserve after laparoscopic ovarian cystectomy with reduced port number: a randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2014 May;176:34-8. doi: 10.1016/j.ejogrb.2014.02.025. Epub 2014 Feb 20.
Results Reference
derived

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The Impact on Ovarian Reserve After Single-port, Two-port, or Four-port Access Laparoscopic Ovarian Cyst Enucleation

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